Institutional Biosafety Committee

A University Institutional Biosafety Committee (IBC) has been
created in accordance with requirements set forth in the National
Institutes of Health "Guidelines for Research Involving Recombinant
DNA Molecules". All research investigations involving Recombinant
DNA, infectious agents or oncogenic materials or agents must be
registered with the UBC. All work involving recombinant DNA that is
subject to the current NIH Guidelines must be reviewed and approved
by the IBC before such work can begin.

RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS ENGAGED IN RESEARCH WITH RECOMBINANT DNA MOLECULES, INFECTIOUS AGENTS, OR ONCOGENIC MATERIALS OR AGENTS.

In order to expedite the processing of applications and to
provide appropriate, deliberate review of proposals, the committee
has developed additional guidelines which are specific to its
needs. Each investigator contemplating initiation of such work must
adhere to the following:

Two months prior to the proposed starting date of research
involving recombinant DNA, infectious agents or potentially
oncogenc materials, or preferably at the time a grant application
is submitted, the PI must complete an IBC
Registration Document to be submitted to the IBC
Secretary.

As early as possible in the planning stage of the research, the
Principal Investigator (PI) should contact EH&S to discuss
plans for physical facilities and possible renovations that may be
needed. Final certification of the Physical Level (BL) of
containment will be made by the University Biosafety Officer.

After IBC has received all documents requested, it may be
expected that the following steps will take place for proposed
work:

For those experiments involving work at a higher level than BL
1, a site visit may be made to the laboratory by a subcommittee of
the IBC. The Principal Investigator shall determine the level of
containment required by his protocol.

A meeting of the IBC will be held to review the documents
submitted and to receive a report on the site visit and a
certification of the BL level of containment. The PI may be asked
to appear before the committee to provide additional
information.

When research is first initiated, rules for observing the proper
BL level of containment must be posted in the laboratory. Any
changes in the names, addresses and phone numbers of persons
employed in laboratories engaged in these studies must be reported
to the Secretary of the IBC.

Training of Laboratory Personnel: It is the prime
responsibility of the PI to provide instruction regarding specific
techniques for research and dangers of materials to be handled and
to document this training. It is the responsibility of the PI to be
certain that all technical personnel are familiar with these
sections of the NIH Laboratory Safety Monograph and the Biosafety
in Microbiological and Biomedical Laboratories (5th Edition)
that pertain to techniques being employed. The PI can obtain
assistance in these matters from EH&S. It is recommended that
all technical personnel and students attend courses on general
laboratory safety organized by EH&S.

Reinspection of Facilities: The Biosafety Officer will make
periodic inspections of major equipment items such as biological
safety hoods, autoclaves, etc., in order to insure proper
containment of agents being used.

Health Surveillance: Beyond the minimum requirements stated
in the NIH Guidelines for the reporting of extended illnesses and
accidents, the PI may initiate other measures such as those
discussed in the NIH Laboratory Safety Monograph. Examples of such
additional measures could include periodic physical and medical
examinations or collection and maintenance of serum samples. The
health status of a laboratory worker may place that person at
increased risk in any endeavor where infectious agents are handled.
Examples given in the Laboratory Safety Monograph include
gastrointestinal disorders and treatment with steroids,
immunosuppressive drugs or antibiotics. Workers with such disorders
or treatment should be evaluated to determine whether they should
be engaged in research with potentially hazardous organisms during
their treatment or illness. The IBC will determine the necessity,
in connection with each project, for health surveillance of
recombinant DNA research personnel, and conduct, if found
appropriate, a health surveillance program for the project.

The following procedures must be observed for making changes in an
on-going research program:

Minor changes in the Registration Document can be approved by
the Secretary of the IBC. A statement in writing by the PI must be
sent to the Secretary as a matter of record.

Major changes in the proposal will require a revised
Registration Document submitted to the Secretary of the IBC.
Examples of such major changes are (a) a significant change in
hosts or vectors; (b) a significant change in the donor species or
the nature of the DNA segment selected; (c) a major change in the
physical location of the experiments; or (d) a change of the
responsible investigator. A renewal notice will be sent to all
registered investigators by the IBC.

Meetings of the IBC will be open to the public, provided
sufficient notice is given to the chairman so that adequate meeting
space can be obtained. Only those parts of meetings dealing with
privileged information (i.e., technical details of grant
applications that have not been approved and funded) will remain
closed. EH&S will maintain, for public viewing, minutes of
committee meetings, information about future meetings, a lay
summary of each recombinant DNA proposal submitted by principal
investigators, and a list of reference material helpful to an
understanding of the procedures involved in studies of recombinant
DNA molecules.